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Effects of Intravenous GC4419 on the Incidence and Severity of Esophagitis Due to Chemoradiotherapy for Lung Cancer

NCT04225026 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-03-23

Study results available
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Summary

GTI-4419-203 will be an open-label, multi-center study to evaluate GC4419 (avasopasem manganese) administered intravenous (IV) for the reduction of radiation induced esophagitis in subjects receiving chemoradiotherapy for unresectable Stage 3A/3B or post-operative Stage 2B Non-Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) treatable with chemoradiotherapy.

Conditions

  • Esophagitis

Interventions

DRUG

GC4419 (avasopasem manganese)

90 mg, by 60-minute IV infusion, prior to each fraction of RT

Sponsors & Collaborators

  • Galera Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Eugene Kennedy, MD · Chief Medical Officer

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-19
Primary Completion
2021-12-28
Completion
2022-03-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04225026 on ClinicalTrials.gov